AnemiaPhase 2NCT00721188

Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients

A Phase 2 study testing Venofer in people with Anemia, run by American Regent, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients. Read more about this study

Who is it for?: Ages 12 to 16 years
Conditions the study is for: Anemia
What is being tested?: Venofer
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Jan 2006to Jan 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Age > or = 12 to < or = 16 years
Parent and/or legal guardian able to give informed consent
Subject able to give written assent for participating in the study
NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
Hemoglobin indicative of anemia
Ferritin indicative of iron deficiency anemia
If appropriate, subject must be willing to use an accepted form of birth control from time of screening through the follow-up period

Who cannot join

Known history of hypersensitivity to any component of Venofer
Parenteral iron within 14 days of the screening visit
Dialysis dependent-CKD
Chronic or serious active infection
Pregnancy or lactation
Subjects with causes of iron deficiency anemia other than CKD

Show all 9Show fewer

Blood transfusion within the last month or anticipated during the study
Body weight < 55 pounds
Received an investigational drug within 30 days before screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Luitpold Pharmaceuticals
Norristown, Pennsylvania, 19403

Other trials in United States

About this study

Official title: Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

Conditions: Anemia
Being tested: Venofer
Medical subject headings: Anemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VenoferDrug
Single dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.

Study groups in NCT00721188
Study group	Role	What they receive
Pharmacokinetic Population	Experimental	All subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose. Receives: Drug: Venofer

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Serum Concentration (Cmax)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Time to Maximum Serum Concentration (Tmax)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Serum Terminal Phase Elimination Half-life (T1/2)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Terminal Phase Elimination Rate Constant (λz)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.

Secondary outcomes (6)

Total Body Clearance (Cl)
Total body clearance: Cl = Dose/Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.
Initial Volume of Distribution (Vdc)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Volume of Distribution Based on the Terminal Phase (Vdarea)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Volume of Distribution at Steady State (Vdss)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Mean Residence Time (MRtime)
Measured: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Number of Participants With Serious Adverse Events (SAE's)
Measured: Day of initial treatment with Venofer through 30 days after study treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Jan 2010

First posted23 Jul 2008 (estimated)
Study startJan 2006
Primary completionJul 2008
Study completionJan 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AnemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00721188
Sponsor's protocol ID: 1VEN05033
Status last verified: Jan 2018
First submitted: 21 Jul 2008
Last updated: 20 Feb 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
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All Anemia trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Dose Pharmacokinetics of Venofer (Iron Sucrose Injection) in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients Receiving or Not Receiving Erythropoiesis Stimulating Agents (ESA's)
ClinicalTrials.gov ID: NCT00721188
Acronym / sponsor ID: 1VEN05033
Conditions: Anemia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: American Regent, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Jul 2008 (actual)
Study completion: Jan 2010 (actual)
First posted: 23 Jul 2008 (estimated)
Results: Posted 25 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to assess the pharmacokinetics of Venofer (Iron Sucrose Injection) in NDD-CKD pediatric patients.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pharmacokinetic Population	Experimental	Drug: VenoferAll subjects who received study drug and completed Pharmacokinetic testing through 24 hours post-dose.

Who may qualify

Ages: 12 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

Age > or = 12 to < or = 16 years
Parent and/or legal guardian able to give informed consent
Subject able to give written assent for participating in the study
NDD-CKD defined as: kidney damage for 3 months or longer, or GFR < 60 for 3 months or longer
Hemoglobin indicative of anemia

Key exclusion criteria (9 listed)

Known history of hypersensitivity to any component of Venofer
Parenteral iron within 14 days of the screening visit
Dialysis dependent-CKD
Chronic or serious active infection
Pregnancy or lactation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VenoferSingle dose of 7mg intravenous (IV) of iron per kg of body weight for a maximum of 200mg iron IV.	Drug	Pharmacokinetic Population

Primary outcome

Maximum Observed Serum Concentration (Cmax)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Time to Maximum Serum Concentration (Tmax)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Serum Terminal Phase Elimination Half-life (T1/2)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Area Under the Serum Concentration-time Curve Extrapolated to Infinity (AUC 0-∞)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Terminal Phase Elimination Rate Constant (λz)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.

6 secondary outcomes

Total Body Clearance (Cl)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours.
Initial Volume of Distribution (Vdc)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Volume of Distribution Based on the Terminal Phase (Vdarea)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Volume of Distribution at Steady State (Vdss)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Mean Residence Time (MRtime)
Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.
Number of Participants With Serious Adverse Events (SAE's)
Time frame: Day of initial treatment with Venofer through 30 days after study treatment

Results and safety

Results posted to the registry on 25 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Venofer (Iron Sucrose Injection)	11	11

Primary outcome: Maximum Observed Serum Concentration (Cmax)

Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.. Mean (Standard Deviation). Unit: ug/dL

Measure	Venofer (Iron Sucrose Injection) n = 9
Value	8545.33 (4118.54)

Primary outcome: Time to Maximum Serum Concentration (Tmax)

Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.. Mean (Standard Deviation). Unit: hour

Measure	Venofer (Iron Sucrose Injection) n = 9
Value	0.56 (0.17)

Primary outcome: Serum Terminal Phase Elimination Half-life (T1/2)

Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.. Mean (Standard Deviation). Unit: hour

Measure	Venofer (Iron Sucrose Injection) n = 8
Value	8.04 (4.51)

Primary outcome: Area Under the Serum Concentration-time Curve From Time of Dosing to the Last Quantifiable Measurable Serum Concentration (AUC 0-last)

Time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.. Mean (Standard Deviation). Unit: ug*hr/dL

Measure	Venofer (Iron Sucrose Injection) n = 9
Value	31304.84 (9850.48)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day of initial treatment with Venofer through 30 days after study treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Venofer (Iron Sucrose Injection)	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Venofer in people with Anemia, run by American Regent, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Serum Concentration (Cmax) (time frame: Pre-dose and post-dose at 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, and 12 hours.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00721188.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.